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The randomized FORTE/NRG-CC005 trial, which is evaluating the frequency of surveillance colonoscopy in individuals with a first-time presentation and removal of 1 to 2 small, benign polyps, has been launched.
The randomized FORTE/NRG-CC005 trial (NCT05080673), which is evaluating the frequency of surveillance colonoscopy in individuals with a first-time presentation and removal of 1 to 2 small, benign polyps, has been launched, according to a news release from NRG Oncology, the sponsor of the trial.1
“The best timing for a repeat colonoscopy for people with 1 or 2 small benign polyps removed during colonoscopy is not known. This study will measure and compare the colorectal cancer [CRC] incidence rates in the two study groups. If the cancer rates are similar to each other, then a 5-year follow-up surveillance colonoscopy exam may not be needed,” said Robert E. Schoen, MD, MPH, principal investigator of FORTE [Five- or Ten-Year Colonoscopy for 1 to 2 Non-Advanced Adenomatous Polyps] and chief of the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh Department of Medicine.
Prior research has shown that the optimal timing for CRC surveillance with colonoscopy is between 5 or 10 years.2
As such, in the open-label study3, individuals who had 1 or 2 adenomatous polyps removed during colonoscopy will be randomized to their next colonoscopy exam at 5 years and at 10 years or at 10 years only.
The primary end point is the rate of colorectal cancer incidence between the 2 study cohorts. Additional outcome measures include incidence of advanced adenoma, CRC mortality, and incidence of stage III to IV CRC, all at 10 years.
The study is expected to enroll 9500 participants aged 50 to 70 years; approximately 4750 individuals will be enrolled in each study group. Patients will be followed up annually as part of the prevention trial.
Those who have a prior history of CRC or colorectal adenomas, including sessile serrated polyps/adenomas but excluding those found on the qualifying colonoscopy, are excluded from enrollment on FORTE.
“In addition to FORTE answering the critical question about best practices for management of people found to have 1 to 2 small polyps on colonoscopy screening, participants are being asked to provide blood, stool, and other tissues for additional studies to help us better understand how colorectal cancer develops from a polyp,” Philip E. Castle, PhD, MPH, director of the Division of Cancer Prevention at the National Cancer Institute (NCI), said in the news release.
FORTE is being conducted through a collaboration with the NCI Community Oncology Research Program and the National Clinical Trials Network. NRG Oncology, which Is funded by grants from the NCI, will head the trial alongside the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, and SWOG.